A randomized controlled trial comparing outcomes of labour induction with transcervical Foley catheter and oxytocin with oxytocin alone in women with previous one caesarean section and pre labour rupture of membranes with an unfavourable cervix at 36 weeks and beyond
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- To compare the rate of vaginal delivery between those induced with transcervical Foley catheter followed by oxytocin with that of oxytocin induction alone
研究概览
简要总结
This prospective randomized controlled trial compares transcervical Foley catheter followed by oxytocin vs oxytocin alone for labor induction in women with one previous cesarean, premature rupture of membranes, and an unfavorable cervix at 36 weeks and beyond. It assesses efficacy, safety, and maternal and neonatal outcomes.Mechanical method like transcervical Foley catheter has gained popularity as safer alternatives to prostaglandins for cervical ripening in women with previous cesarean delivery, as they avoid the risks of uterine rupture associated with pharmacological ripening agents.Induction with transcervical foleys catheter followed by oxytocin would be more efficacious in reducing the use of uterotonic agents and induction delivery interval thereby increasing VBAC rate and decreasing the risk of scar dehiscence and scar rupture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant women with previous one caesarean section and premature rupture of membranes,eligible for TOLAC at 36 weeks and above.
- •2.Age: 20-35 years 3.Singleton pregnancy with cephalic presentation 4.Rupture of membranes less than 12 hours duration 5.Bishop score of less than or equal to 4 at admission.
- •6.Clear liquor at recruitment.
排除标准
- •1.Clinical evidence of chorioamnionitis 2.Severe preeclampsia 3.Heart disease (RHD/ Congenital – uncorrected) 4.People living with HIV/AIDS 5.Severe anemia 6.Diabetes mellitus on Insulin therapy.
结局指标
主要结局
To compare the rate of vaginal delivery between those induced with transcervical Foley catheter followed by oxytocin with that of oxytocin induction alone
时间窗: At 24 hours | At 48 hours
次要结局
- Maternal outcome in terms of chorioamnionitis and uterine scar rupture.(At 24 hours of intervention)
- Neonatal outcome in terms of APGAR scores at 1 and 5 minutes, NICU admissions, and neonatal sepsis.(At 24 hours of intervention)
研究者
Dr Dharshini K K
Jawaharlal Institute of Postgraduate Medical Education and Research